Precision-Guided (MALT-Targeting) Mucosal Vaccines

          The previous pages in this website describe a number of specific points which now need to be assembled into a larger, cohesive structure or system:

          (1) Nearly all pathogens have evolved in ways that enable them to attack and invade mucosal membranes, and they are (by far) the most important and numerous class of pathogens on this planet;

          (2) The internal immune system simply is not designed, equipped, or suited, to deal with pathogens that can reproduce – usually, very rapidly – entirely within a single cell, in the outermost surface layer of a mucous membrane;

          (3) Therefore, to help fight off such pathogens, vertebrate animals evolved with mucosal immune systems that function independently of the internal defenses, and use secreted mucosal IgA antibody dimers which are very different from internal IgG antibodies, in both shape and function;

          (4) There are more than twice as many mucosal antibodies, in just the few pounds of secreted mucosal fluids in a healthy adult, than all of the internal antibodies in the entire remaining weight and bulk of that person; and,

          (5) The huge number of secreted mucosal antibodies is powerful and even compelling evidence that mucosal antibodies are hugely important, and valuable, in fighting off mucosal pathogens.

 

          All five of those points directly support an entirely logical conclusion: if any types of vaccines could trigger the creation of good and effective secreted mucosal antibodies, those vaccines (and the antibodies they would help create) could be very useful, and helpful, against numerous different types of pathogens – especially pathogens that attack the “upper respiratory tract” (such as influenza, COVID, and “common cold” viruses).

          However, the sad and troubling fact is that, under the “prior art” (i.e., before the scientific community becomes aware of “MALT-targeting” vaccines), there are almost no “really good” mucosal vaccines; and, there is almost no research currently being done on mucosal vaccines, because the only types of “adjuvants” which can make them work potently, in test animals, are too dangerous, and too toxic, to allow the results of any such research to be transferred over, to possible use in humans.

          Here are four facts that can help illustrate, and explain, the limited and inadequate status of mucosal vaccines, prior to any announcements about MALT-targeting vaccines.

          1. Even though there are hundreds (or thousands, depending on how different strains and variants are classified) of different mucosal pathogens, a recent review article dedicated entirely to mucosal vaccines (Rhee et al, “Mucosal vaccine adjuvants update,” Clin Exp Vaccine Res 1: 50-63 (2012)) listed all of the commercially available human mucosal vaccines that the authors could find information about. However, that listing took less than a single paragraph, and it didn’t even merit a table, to list them.
         2. The so-called “FluMist” vaccine, which is administered via a nasal spray, usually reaches only about 30 to 40% efficacy, each year. Those numbers mean that 60 to 70% of the people who get that vaccine, still become infected by serious cases of influenza, each year, despite being vaccinated by it.
         3. The most recent attempt to create a new nasally-delivered vaccine occurred in Switzerland, where a mucosal influenza vaccine was put into human use. However, even though it had performed well in animal tests, it ended up causing some of the human recipients to suffer a neurologic affliction called “Bell’s palsy,” which creates a partial paralysis of the facial muscles, usually on either the left or the right side of the face. As such, it can lead to strange, unsettling, sometimes bizarre, and in some cases grotesque and genuinely frightening facial expressions, among sufferers. That vaccine had to be withdrawn from the market when those cases began to appear, and the manufacturer was driven out of business, by the costs of the liabilities it was facing. That event is well and widely known, among vaccine experts, and it powerfully discourages any companies or researchers that might otherwise be tempted to launch an expensive research project into any other potential mucosal vaccine, no matter how promising it might be.
         4. It appears that the only mucosal vaccine which has actually been commercialized for human use, since the year 2000, is an orally-ingested vaccine against “rotaviruses” (which create severe digestive problems among infants, in tropical regions). However, the first attempt to release that vaccine led to major problems, and that first version had to be withdrawn, after it began causing a severe and potentially fatal intestinal problem called “intussusception” – which must be corrected surgically, as quickly as possible – in some of the infants who received that vaccine. The sponsoring company re-designed and re-tooled that vaccine, by reducing the number of rotavirus antigens the virus particles carried (which presumably made it somewhat less effective). It is now being sold under the trademark ROTA-TEQ (TM).

​          More information to support and explain the facts listed above (and which further discusses the severe inadequacies of currently-available mucosal vaccines) is contained in the “Background Section” of a pending (not yet published) patent application, which can be downloaded via a button at the bottom of the Home page. 

          Accordingly, mucosal vaccines simply are not being actively and successfully developed, for human use, except by a few small startup companies, none of which appear to be taking the approach we are taking; and, vaccines which are injected almost never lead to mucosal antibody formation. That has created a huge and unmet need, for better methods for creating, not just vaccines that can be APPLIED topically to mucous membranes, but which will actively trigger the formation of secreted mucosal antibodies, when applied in that manner.

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